BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 22731255 · Received August 6, 2025

    Report

    Report Number
    2124215-2025-53190
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 14, 2025
    Report Date
    February 27, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK D4: UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4). BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. BLOCK H11: INVESTIGATION DETAILS: THE DEVICE ANALYSIS WAS PERFORMED. DEVICE INSPECTION SHOWED ZERO ISSUES. DEVICE LOGS SHOW FUNCTIONAL BEHAVIOR. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. DEVICE INVESTIGATION SHOWED ZERO ISSUES. THE IPG WAS FUNCTIONAL AND MEASURED IMPEDANCES USING A TEST LEAD WERE ACCEPTABLE. NO PROBLEM DETECTED WAS CHOSEN AS CONCLUSION CODE. NO ISSUES RELATED TO IMPEDANCE WERE SEEN DURING INVESTIGATION. CORRECTION: BLOCK G2: REPORT SOURCE.

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT STATED THEIR DEVICE HAS NOT WORKED. THE PATIENT HAD HIGH IMPEDANCE. THE CLINICAL SPECIALIST TRIED TO CONNECT TO THE DEVICE, BUT THERE WAS NOTHING THAT COULD BE DONE. THE PATIENT HAD THEIR TINED LEAD AND NEUROSTIMULATOR EXPLANTED ON (B)(6) 2025. THE PATIENT IS NOT CONSIDERING A RE-IMPLANT. THE PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT STATED THEIR DEVICE HAS NOT WORKED. THE PATIENT HAD HIGH IMPEDANCE. THE CLINICAL SPECIALIST TRIED TO CONNECT TO THE DEVICE, BUT THERE WAS NOTHING THAT COULD BE DONE. THE PATIENT HAD THEIR TINED LEAD AND NEUROSTIMULATOR EXPLANTED ON (B)(6) 2025. THE PATIENT IS NOT CONSIDERING A RE-IMPLANT. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288650 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H177305 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention TINED LEAD, 1201, SERIAL NUMBER IS UNKNOWN.